Study Stopped
Study was closed due to low subject enrollment at site.
Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine
A Phase II Pilot Study of Disulfiram and Copper Gluconate in Patients With Metastatic Pancreatic Cancer and Rising CA-19-9 Levels While Receiving Abraxane-Gemcitabine or FOLFIRINOX or Single-Agent Gemcitabine
1 other identifier
interventional
1
1 country
1
Brief Summary
This is an open-label Phase 2 Pilot study to evaluate Disulfiram + Copper Gluconate in patients metastatic pancreatic cancer whose CA-19-9 levels rise while receiving nab-paclitaxel (Abraxane) plus gemcitabine (Gemzar) or FOLFIRINOX or single-agent gemcitabine (Gemzar). Patient must have received a minimum of 8 weeks of treatment and have rising CA-19-9 levels in the absence of radiographic evidence of progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 22, 2018
CompletedStudy Start
First participant enrolled
October 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2020
CompletedResults Posted
Study results publicly available
October 18, 2023
CompletedOctober 18, 2023
September 1, 2023
9 months
October 9, 2018
August 24, 2023
September 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
CA19-9 Plasma Level
Change in plasma CA19-9 level (at least 30%) from baseline
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary Outcomes (9)
Complete Tumor Response
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Partial Response
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Stable Disease
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Response Rate
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival
From date of enrollment until date of death assessed up to 100 months
- +4 more secondary outcomes
Other Outcomes (1)
Disulfiram/Copper Gluconate Serum Levels - Area Under the Curve (AUC)
Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7
Study Arms (3)
Nab-Paclitaxel/Gemcitabine + DSF/Cu
ACTIVE COMPARATORSubjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
FOLFIRINOX +DSF/Cu
ACTIVE COMPARATORSubjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Single-Agent Gemcitabine +DSF/Cu
ACTIVE COMPARATORSubjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Interventions
Complete blood cell count (CBC) w Differential, comprehensive metabolic panel (CMP), Prothrombin time/international normalized ratio (PT/INR) Activated Partial Thromboplastin Time (aPTT), Urinalysis
Assessment of Adverse Events (AE)
Physical Exam, Weight, Vital Signs, Eastern Cooperative Oncology Group (ECOG) Performance Status
Prior and Concomitant Medication Review
Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed adenocarcinoma of the pancreas that is metastatic and for which potential curative measures, such as resection of an isolated metastasis, are not available. Patients with islet cell neoplasms are excluded.
- Patient should currently be receiving a chemotherapy regimen comprising FOLFIRINOX or Abraxane-Gemcitabine or single-agent Gemcitabine as front-line treatment for metastatic disease. Patients who have had chemotherapy in the adjuvant or neoadjuvant setting are eligible.
- Patients must have previously received a minimum of 8 weeks of therapy with Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine without radiographic evidence of disease progression based on the investigator's opinion, but a rising CA 19-9 level, and still be undergoing treatment with Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine. Increased CA 19-9 is defined as an increased over baseline of \> 20% in two consecutive time points within 8 days of each other.
- Patient has one or more metastatic tumors measurable by CT scan. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.
- Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
- Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100,000/mm3 (100 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL.
- Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0:
- aspartate aminotransferase (AST) (SGOT), Alanine Transaminase (ALT) (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are present, then ≤ 5 × ULN is allowed. Total bilirubin ≤ 1.5 × ULN.
- Serum creatinine \< 1.5X ULN or estimated creatinine clearance of \> 60 mL/min (per Cockroft-Gault formula)
- Patient has ECOG performance status from 0 to ≤ 1.
- Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
You may not qualify if:
- Patient has brain metastases.
- Patient has experienced an increase of ECOG to \> 1 between Screening and enrollment.
- QTc \> 480 msec if patient receiving oxaliplatin-containing regimen.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has a history of allergy or hypersensitivity to any of the study drugs, their pharmaceutical class or any of their excipients. The patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of Gemcitabine or Abraxane ® Prescribing Information package inserts or on the Investigator's Brochure for DSF/Cu.
- Patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity.
- Patient is enrolled in any other clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer.
- Patient is unwilling or unable to comply with study procedures.
- Abraxane is metabolized by CYP2C8 and CYP3A4. Co-administration of substrates, inhibitors of CYP2C8 (see Appendix C) and/or CYP3A4 (see Appendix D) with Abraxane is not allowed. The following medications and substances are not allowed during the study: ritonavir, saquinavir, indinavir, nelfinavir, rifampicin, carbamazepine, phenytoin, efiravenz, or nerivapine, grapefruit (juice or seeds) or some herbals like St. John's wort.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HonorHealth Research Institutelead
- Cantex Pharmaceuticalscollaborator
Study Sites (1)
HonorHealth Research Institute
Scottsdale, Arizona, 85251, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gayle Jameson, MSN, ACNP-BC, AOCN
- Organization
- HonorHealth
Study Officials
- PRINCIPAL INVESTIGATOR
Gayle Jameson, ACNP-BC
HonorHealth Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 22, 2018
Study Start
October 17, 2019
Primary Completion
July 22, 2020
Study Completion
July 29, 2020
Last Updated
October 18, 2023
Results First Posted
October 18, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share